Registration Dossier
Registration Dossier
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EC number: 701-428-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: US FEDERAL REGISTER 38 NO. 187, Paragraph 1500.42 page 27019 of 27. SEPT. 1973
- GLP compliance:
- no
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- green powder
Constituent 1
- Specific details on test material used for the study:
- Heliogengrün 9140
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 3 - 4 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 45 - 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing after application
SCORING SYSTEM: Draize
Time points investigated: 1h, 24h, 72h, and longer if needed
TOOL USED TO ASSESS SCORE: not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable, since no findings
- Irritation parameter:
- iris score
- Basis:
- other: all six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since no adverse findings
- Irritation parameter:
- conjunctivae score
- Basis:
- other: all six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable, since no adverse findings
- Irritation parameter:
- chemosis score
- Basis:
- other: all six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since no adverse findings
- Irritant / corrosive response data:
- One hour after the application, two rabbits showed slight wetness of the treated eyes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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